After years of revisions and anticipation, the compendial standards outlined in USP General Chapters <795>, <797>, and <800> became applicable as of November 1, 2023. This milestone marked a significant shift in pharmaceutical practices, especially concerning sterile compounding. As teams adjust their cleaning, Beyond Used Date’s (BUD), and operations to be compliant with the updated guidelines lets walk through some tips to ensure your hospital and health system can be compliant.
Build a Systematic Tracking Program for Ongoing Compliance:
The importance of establishing a systematic tracking program to ensure ongoing compliance with USP standards is a foundation in establishing a benchmark. By convening a team of sterile compounding experts and developing a USP <797> tracker, health systems can make sure they align their practices while allowing variations related to hours of operation, but not in quality performed. If you are a single hospital, networking with similar hospitals will answer some questions and provide confidence in decisions.
Put an Expert in Charge Systemwide:
The decision to hire a pharmacy leader with expertise in sterile compounding for the entire system to oversee compliance efforts has become necessary. Standardization and alignment become paramount, and having a systemwide expert facilitates this process. The advancement of best practices in our industry are often shared at conferences, during webinars and as the saying goes “rising tides raises all boats”, investing in this role can help close the gaps.
Vague Policies/Procedures Are Not Your Friend:
Clear and specific documentation is essential to guide team members effectively and mitigate risks during compounding processes. Developing thorough policies (and corresponding procedures) that outline specific steps and protocols will remain crucial for ensuring adherence to standards. Once these are in place, be willing to adjust to the tribal knowledge developed from those who perform the work. This includes updating the policies/procedures, based on the documentation and automated checklists they use to manage daily expectations.
Expect Extra Challenges in Category 3:
Category 3 pharmacies face unique challenges, including more frequent competency assessments and stringent requirements for sterile garb. This can be a logistical complexity for team members involved in maintaining compliance for high-risk compounding activities and emphasizes the need for meticulous planning and resource allocation. While we never wanted to “guess” what was done with our sterile preparation, its never to late to remove guestimations in what your team is expected to perform.
Conclusion:
The journey to USP compliance presents various challenges and complexities for pharmacy institutions, but it also offers valuable opportunities for improvement and innovation. By implementing systematic tracking programs, appointing dedicated experts, developing clear policies, and investing in supportive systems, pharmacies can navigate the road to compliance more effectively. Furthermore, anticipating extra challenges in Category 3 compounding and preparing for terminal sterilization can help institutions proactively address potential obstacles. As pharmacies continue to adapt to evolving standards, sharing lessons learned and best practices will be instrumental in advancing pharmacy practice and enhancing patient safety, and we would like to partner with you in your journey!
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